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Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease

NCT06943482 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-24

No results posted yet for this study

Summary

This research study is to determine the effectiveness of prednisolone and methotrexate for IGM patients over a period of one year, in terms of clinical and radiological response. Recruitment will be conducted in National University Hospital (NUH) for patients diagnosed with IGM.

Conditions

  • Idiopathic Granulomatous Mastitis

Interventions

DRUG

Prednisolone

20mg of prednisolone will be prescribed, taken orally, and daily for first month followed by tapering doses of 15mg over one month, then 12.5mg for one month, proceeding to 10mg for one month, subsequently taking 7.5mg for one month, and lastly 5mg for one month.

DRUG

Methotrexate

10mg of methotrexate will be prescribed to be taken once a week for one month. The dosage will be increased to 15mg of methotrexate taken once a week on the 1st (T1) month clinical visit and will be further increased to 20mg of methotrexate taken once a week on the 2nd (T2) month clinical visit. There will be no further escalation of dosage after this visit.

DRUG

Folic Acid 5 MG

5mg of folic acid is to be taken together with methotrexate once a week.

DRUG

Omeprazole 20 mg

Omeprazole will be prescribed at 20mg to protect the stomach lining.

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Serene Si Ning Goh, MBBS · National

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2028-02-01
Completion
2028-02-01

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06943482 on ClinicalTrials.gov